The complaints accuse Baxter and its supplier, Scientific Protein Laboratories LLC, of negligence, alleging Baxter’s heparin was unsafe for the intended use. The lawsuits seek money damages.

The nightmare began in late 2007, as reports of serious allergic reactions and deaths following use of Baxter’s heparin began mounting. By March 2008, the Food and Drug Administration (FDA) issued a major recall of heparin. At the time, Baxter supplied about 50 percent of heparin to the U.S. As Baxter began pulling its heparin, investigations into the source of the contaminant focused on Baxter International’s China plant. The culprit was identified as over-sulfated chondroitin sulfate, or OSCS, a man-made chemical that mimics heparin.

While Baxter was at fault for distributing the tainted heparin, critical eyes fell on the FDA for not properly inspecting foreign drug manufacturing plants. The agency admitted it was simply too understaffed to properly inspect most of the foreign food and drug manufacturing plants. The FDA soon after received funding to open overseas field offices, the first three of which were opened in China.

The stricter inspections hardly console the victims and families of victims who suffered or died from the contaminated blood thinner. The FDA reports that as many as 395 deaths and 785 reports of serious injury were associated with the contaminated heparin.

Source: Bloomberg

SOURCE: Heparin Recall › Baxter faces numerous lawsuits over tainted heparin scandal

Announcement of the deaths and illness at Beebe Medical Center in Lewes, Delaware, raised immediate concern at the hospital, which promptly notified the FDA and Baxter. The incidents were far too similar to the 2007 heparin scandal in which more than 80 Americans died and hundreds more became ill after receiving doses of Baxter’s heparin. An investigation found some lots of heparin manufactured in Baxter’s China factory were contaminated with a heparin-like substance called over-sulfated chondroitin sulfate, or OSCS.

Both Baxter and the FDA investigated the Beebe incidents. Earlier this week Baxter announced its investigation found no OSCS contaminate in the heparin supplied to Beebe. It also said the heparin used by Beebe was manufactured in its Ohio plant, not the China facility.

But the mystery about the deaths and illness at Beebe still remains. A Baxter spokesperson said that following the national guidelines for drugs like heparin does not guarantee that there will be no problems with the medication.

“Even when those protocols are followed, bleeding at a site, including intercranial bleeding, can occur – especially in high-risk patients, which is an established side effect of all anticoagulant therapies,” said Erin Gardiner with Baxter. “Our responsibility is for the safety of the product.”

Source: Delmarva Media Group

SOURCE: Heparin Recall › FDA clears Baxter in deaths following heparin injections

Two deaths and one illness earlier this month following the injection of heparin in patients at a Lewes, Delaware, hospital sent chills through the nation. Could this be a repeat of the deadly contamination that harmed so many in 2007? The vials of heparin were traced back to Baxter, however these doses were manufactured in Ohio, not China, the drug maker contends.

Last year’s OSCS contaminant caused victims to suffer severely low blood pressure. This new reaction involves intracranial bleeding. Investigations by both Baxter and the Food and Drug Administration (FDA) followed and early findings indicate there is no trace of OSCS in the heparin used. Now Baxter says it is confident that the events at the Delaware hospital were “isolated, institution-specific issues, unrelated to the quality of Baxter’s heparin premix product,” a Baxter spokesperson told the Reuters news organization.

According to Baxter, it obtained samples from the lot in question as well as lots produced before and after the lot in question. Testing on those lots confirmed that the product’s formulation was within specifications and met all requirements. The FDA backed up Baxter’s contention: “We don’t see a quality problem with the product,” an FDA spokesperson said.

SOURCE: Heparin Recall › Baxter says it’s not responsible for recent heparin deaths, illness

All three incidences occurred at the Beebe Medical Center in Lewes, Delaware, and all three were given heparin supplied by Baxter, the same drug company at the center of last year’s contaminated heparin scandal. That heparin, which killed more than 80 people and injured hundreds more, was manufactured in China. The latest batch was manufactured in Ohio.

The heparin in question involves premixed intravenous bags of heparin whereas the previous heparin, which was later found to have been contaminated with a heparin-mimicing substance called over-sulfated chondroitin sulfate (OSCS), involved vials of the medicine and drug-coated medical devices.

The symptoms suffered from the newest victims involved intracranial bleeding; the previous deaths and illnesses were caused by severely low blood pressure. Immediately following the adverse reactions, the hospital contacted Baxter, which immediately contacted the FDA.

Both Baxter and the FDA sent medical teams to Delaware and the FDA took samples of the heparin for testing. “As far as we can determine at this point, it appears to be an isolated incident,” says FDA spokewoman Karen Riley.

Baxter has tested for but not found the contaminant OSCS to be in the batches of heparin taken from Beebe Medical Center. Baxter insists the heparin used on the patients who became ill at Beebe was not manufactured in China but in North America.

SOURCE: Heparin Recall › New deaths, illness following heparin use spark FDA investigation

Rep. Joe Barton

The FDA has previously claimed the raw heparin originated from a manufacturing company in China and was purposefully contaminated with a man-made chemical, over-sulfated chondroitin sulfate, OSCS. The Chinese government disagrees.

Barton, a ranking member of the House Energy and Commerce Committee, has long championed the effort to resolve the heparin scandal by scrutinizing the FDA’s investigation into the case and the subsequent recall. He has previously argued that the agency misrepresented deaths tied to the heparin and didn’t thoroughly investigate the matter. He also has demanded answers on why the FDA took six months to seize lots of the contaminated heparin from an Ohio agency that still had the tainted drug in stock.

In his latest inquiry, Barton wants to know if the FDA has tracked the contamination back to the source. He also asked what action the Chinese government has taken in the matter and whether anyone in China has been held accountable.

Products imported from China have been in the spotlight in recent years as reports of more tainted foods, drugs and toys have entered the U.S. and injured people. The FDA has been working to expand its inspections of foreign imports in part by opening offices overseas. The first of these offices opened late last year in China.

SOURCE: Heparin Recall › Congressman demands answers on tainted heparin scandal

Ralph Sell of Lincoln, Nebraska, says that his wife Alice was undergoing cancer treatments in December 2007 when a syringe contaminated with Serratia marcescens, a bacteria that can cause serious injury or death, was used on her. She suffered high blood pressure, disorientation and sepsis. She died a year later at the age of 82 of “acute respiratory failure.” It has not yet been determined if the contaminated syringe may have led to her death.

Sell filed suit against Baxter International as well as its subsidiary Baxter Healthcare Corp., B. Braun Medical Inc., and AM2 PAT Inc, also known as Sierra Prefilled. A spokesperson for Baxter says the company has no role in the lawsuit, as it does not sell prefilled saline syringes. AM2 PAT did recall saline prefilled syringes in December 2007 and January 2008 because some of the syringes were tainted with the bacteria.

Baxter currently faces numerous lawsuits stemming from a 2008 recall of the blood thinner heparin. Batches of the company’s heparin manufactured in China were found to have been contaminated with over-sulfated chondroitin sulfate (OSCS). The tainted heparin is believed to have contributed to the deaths of more than 80 Americans and caused serious illnesses in hundreds more.

Sell’s lawsuit against the companies seeks unspecified damages and payment for medical costs.

SOURCE: Heparin Recall › Baxter named in contaminated saline syringe lawsuit

The Quaids also sued Baxter Healthcare Corp. over the packaging and labeling of its high-dose and low-dose heparins, arguing the two bottles are easily confused. Other cases of heparin overdose have been reported and linked in part to the confusing packaging. The Quaid’s lawsuit against Baxter was dismissed on jurisdictional grounds because the event occurred in California.

Baxter was no stranger to the spotlight in 2008, facing numerous lawsuits most notably for the tainted heparin scandal earlier in the year. More than 80 Americans died and hundreds more were sickened after receiving doses of heparin made at Baxter China plant. An investigation found that lots made in that plant were contaminated with over-sulfated chondroitin sulfate (OSCS). The contaminant can cause serious allergic reactions and even death. The FDA issued a recall on batches of Baxter’s heparin.

According to news reports, the Quaid-Cedars-Siani case indicates that Baxter may also sue Cedars-Siani for improperly administering the blood thinner to several patients at the hospital, including the Quaid’s newborn twins.

SOURCE: Heparin Recall › Quaid-Cedars-Siani lawsuit over heparin overdose finally closed

Joyce Ann Osteen filed the suit in St. Clair County, Illinois, and claims Baxer purposefully added a contaminant, over-sulfated chondroitin sulfate, or OSCS, to heparin manufactured in its China plant. The tainted heparin was distributed to the U.S., where hundreds of allergic reactions occurred. More than 80 people died and hundreds more were sickened by the tainted heparin before an investigation led to a recall of batches of heparin manufactured at Baxter’s China facility. The FDA later issued an announcement saying that the contaminant was an inexpensive and unapproved ingredient that mimics heparin.

OSCS costs only $9 to produce compared to $900 for heparin, the suit contends.

“The recalled heparin was adulterated, misbranded, defective, unreasonably dangerous and unfit for its intended uses,” the suit states. “Baxter placed tens of thousands of patients, including the Plaintiff at unnecessarily risk of serious injury and/or death.”

The suit states Osteen and the class members who purchased the heparin “suffered actual damages as a proximate result of Baxter Healthcare Corp.’s deception in that they were deprived of the benefit of their bargain.” According to the complaint, Osteen is asking the court to certify the complaint as class action. She also is seeking damages of less than $74,999 per plaintiff or class member.

SOURCE: Heparin Recall › Class action lawsuit filed against heparin manufacturer Baxter

Last year, heparin was thrust into the spotlight after more than 80 patients who had received the blood thinner died and hundreds more became ill. An investigation to the adverse reactions found that batches of heparin manufactured in Baxter International’s China plant were contaminated with over-sulfated chondroitin sulfate (OSCS). That discovery spurred the FDA to recall lots of heparin made by Baxter International.

“Perhaps the most surprising fact that emerged in our three months of reporting on contaminated heparin ingredients from China: The U.S. government has little ability to know whether the drugs we are taking are safe or not,” Eisner points out.

Last month, the FDA vowed to step up its efforts to oversee quality control of imported foods and drugs by opening offices in foreign countries. Its first offices opened in China. The FDA plans to place more than 60 food and drug regulators worldwide over the next several months. However, the agency says it will take more than a decade to adequately inspect all foreign drug manufacturing plants.

“As a result,” Eisner writes, “doctors must take it on faith that the medicines they are prescribing are exactly what they are supposed to be.”

SOURCE: Heparin Recall › Tainted heparin may have caused death of infant

Heparin is generally used when a patient – adult or infant – receives fluids through a central line to prevent a blood clot from forming, which could eventually grow and break off and kill a patient. But if the blood is too thin, it puts the patient at risk for life-threatning bleeding or hemorrhages, including in the brain.

The Quaids also sued Baxter Healthcare Corp. over the packaging and labeling of its high-dose and low-dose heparins, arguing the two bottles are easily confused. Other cases of heparin overdose have been reported and linked in part to the confusing packaging. The Quaid’s lawsuit against Baxter was dismissed, according the Associated Press.

Baxter International has faced numerous lawsuits lately, most notably for the tainted heparin scandal earlier this year. More than 80 Americans died and hundreds more were sickened after receiving doses of heparin made at Baxter International’s China plant. An investigation found that lots made in that plant were contaminated with over-sulfated chondroitin sulfate (OSCS). The contaminant can cause serious allergic reactions and even death. The FDA issued a recall on batches of Baxter’s International’s heparin.

The Associated Press reports that the petition filed Monday in the Quaid-Cedars-Sinai case indicates that Baxter International may also sue Cedars-Sinai for improperly administering the blood thinner to several patients at the hospital, including the Quaid’s newborn twins.

SOURCE: Heparin Recall › Quaids get settlement in heparin overdose case

Franke Leon Isom of Webster, Ken., died Dec. 14, 2007, a day after he was given heparin during treatment at Woodland Dialysis Clinic in Elizabethtown. Attorneys argue that Isom received part of the 55,000 gallons of heparin that was contaminated with over-sulfated chondroitin sulfate (OSCS).

Earlier this year, a series of deaths and adverse allergic reactions from patients who had received doses of heparin led to an investigation that linked the reactions to lots of heparin made at Baxter International’s China plant. Further review found the heparin had been contaminated with OSCS during manufacturing in China. Shortly thereafter, the FDA ordered a recall. The tainted heparin is blamed for more than 240 deaths worldwide and caused hundreds more people to fall ill from allergic reactions to OSCS, such as hypotension.

The lawsuit, filed on the behalf of Isom’s estate, is one of 50 similar civil tort claims against Scientific Protein Laboratories and Baxter International, according to the news report. Attorneys argue that recalled lots of heparin were still found on hospital shelves months after the recall went into effect.

SOURCE: Heparin Recall › Another lawsuit filed in tainted heparin scandal

Heparin from another company, APP Pharmaceuticals Inc., wasn’t considered a problem, though in a letter to Congress in October, the FDA said one patient taking the APP heparin had a severe reaction that may have led to his death, according to the news report. APP responded in a letter to the congressman’s staff that the company had thoroughly reviewed the case and did not believe the patient’s death was a result of contaminated heparin.

Rep. Barton wants to know why the FDA has “no information” about whether that patient’s death was caused by the same contaminant – over-sulfated chondroitin sulfate – as was found in Baxter International heparin.

Rep. Barton has been on the FDA’s case for more than a month, questioning the agency’s handling of the heparin recall, claiming it misrepresented deaths tied to the product , arguing that it didn’t thoroughly investigate the matter, and ordering answers on why the agency took six months to seize lots of contaminated heparin from an Ohio agency.

SOURCE: Heparin Recall › Barton wants answers from FDA about heparin scandal

Von Eschenbach was appointed by President Bush in 2005 after the agency’s previous commissioner resigned due to ethical issues, the AP reports. While under von Eschenbach’s helm, the FDA has undergone scrutiny by Congress and consumer groups over issues such as the tainted heparin scandal earlier this year.

The FDA ordered a recall on batches of the blood thinner heparin made at Baxter International’s Chinese facility after some lots were found to have been contaminated with over-sulfated chondroitin sulfate. The tainted heparin killed more than 80 Americans and sickened hundreds more before the contaminant was identified and linked to the China plant.

Over the past several months the FDA continued to come under fire for its handling of the heparin recall. Last week, Rep. Joe Barton, a ranking member of the House Energy and Commerce Committee, questioned why the FDA waited six months to seize lots of contaminated heparin from Celsus Laboratories in Ohio. Last month Rep. Barton also asked the Government Accountability Office to look into the agency’s overall handling of the recall.

Despite the criticism, von Eschenbach has been favorably regarded for strengthening the agency’s international food and drug regulations, opening three offices in China last month and vowing to place more than 60 food and drug regulators worldwide to oversee quality standards of food and drugs imported to the United States.

President-elect Obama is considering a list of candidates to succeed von Eschenbach that includes Baltimore’s health commissioner, several prominent physicians, and former and current FDA officials, according to AP.

SOURCE: Heparin Recall › FDA commissioner announces plans to resign next month

Earlier this year, the FDA recalled lots of heparin manufactured in a Baxter International Chinese plant after batches were found to have been contaminated with over-sulfated chondroitin sulfate. The FDA recall was the result of an investigation into the deaths of more than 80 people and illnesses of hundreds more people after receiving doses of heparin.

CNN Money reports that the recall process is voluntary. Companies are not required to immediately comply with the FDA’s request, however FDA inspectors reportedly told Celsus Laboratories in April that its recall efforts were insufficient, and a month later followed up in a letter to the company expressing the same concerns. Last month, the FDA seized 11 contaminated lots of heparin from Celsus Laboratories.

The FDA won’t elaborate on why Celsus Laboratories’ efforts were less than satisfactory, saying its investigation into the matter is still ongoing. The agency did say that on occasion it sends safety officers to companies to conduct “100 percent effectiveness checks” to ensure they are taking proper measures to destroy the recalled products.

Rep. Joe Barton, a member of the House Energy and Commerce Committee, has been following the heparin situation and, last month, asked the Government Accountability Office to look into the matter. The congressman also wrote a letter to the FDA commissioner saying he wants to know when the agency first decided it was appropriate to seize heparin from Celsus Laboratories. He also asked for a list of all individuals involved in the decision to seize the heparin.

SOURCE: Heparin Recall › Congressman questions FDA’s slow action on heparin seizure

Researchers identified the contaminant last April and noted how it could lead to severe allergic reactions. This new MIT report documents the reactions and specifically links them to batches of heparin that were manufactured in Baxter International’s Chinese facility. The findings were published in the New England Journal of Medicine.

In an effort to provide guidance on U.S. quality standards and avoid life-threatening contaminations of drugs imported into the U.S., the FDA has begun setting up foreign offices and placing more than 60 food and drug regulators worldwide. Last month, the agency opened its first foreign offices. Three of those first offices were located in China.

Health and Human Services Secretary Michael Leavitt said the foreign offices will send a clear message to producers that if they want access to the American market, they must make products that meet a higher standard of quality.

SOURCE: Heparin Recall › MIT report proves type of contaminant in Chinese heparin

Batches of heparin were recalled by the FDA earlier this year after lots manufactured in China were found to have been contaminated with over-sulfated chondroitin sulfate. The investigation and subsequent recall followed reports of more than 80 deaths and thousands more illnesses of patients who had received doses of heparin from the lots in question.

Rep. Joe Barton, R-Texas, last week pointed out that the FDA made conflicting statements to the public and Congress about the number of deaths caused by the blood thinner. Last May, the FDA said it completed a review of three deaths linked to the tainted heparin. Last month, the FDA told Congress that only two deaths were possibly linked to the incident and the third was “unassessable.”

Baxter International, the company involved in the tainted heparin incident, conducted its own investigation and determined that the contaminant was likely not the cause of death in any of the three cases mentioned by the FDA. Baxter’s investigators reviewed patient medical records, interviewed pharmacists and nurses, and visited a hospital where one of the patients had gone before dying.

The FDA came under fire over the tainted heparin scandal after admitting it did not properly inspect Baxter’s China facility. Inspecting all foreign drug manufacturing facilities could take as long as 13 years, the agency has reported. This week the FDA opened its first foreign office, located in Beijing, China, as part of a push to place more than 60 food and drug regulators worldwide to provide guidance on U.S. food and drug quality standards.

SOURCE: Heparin Recall › Lawmaker questions FDA investigation of heparin scandal

The move is part of the agency’s effort to place more than 60 food and drug regulators worldwide over the next year. The offices replace the FDA’s previous practice of sending staffers on individual assignments to inspect foreign facilities.

The agency’s Beijing office, which opens Wednesday, will be the first. Thirteen employees will be assigned to work in the China offices.

The AP quoted a statement from the office of U.S. Health and Human Services Secretary Mike Leavitt: “Establishing a permanent FDA presence in China will greatly enhance the speed and effectiveness of our regulatory cooperation and our efforts to protect consumers in both countries.”

The FDA is placing offices worldwide with particular attention to India, Latin America and the Middle East. However, placing offices in China became a priority as a result of numerous reports of contaminated food and drug products manufactured in China. Among the products made in China and recalled by the FDA were batches of the blood thinner heparin, which were found to have been contaminated with over-sulfated chondroitin sulfate (OACA). More than 80 Americans and hundreds more fell ill after receiving the contaminated heparin.

SOURCE: Heparin Recall › FDA opens first foreign office in Beijing this week

During dialysis, patients are hooked up to a machine that draws out the blood through tubing. Since blood tends to clot when it moves through the tubing, patients routinely are given the blood thinner heparin to prevent clotting.

One week before Christmas, after two months of regular dialysis, Bonnie fell ill with diarrhea, vomiting and soon, severe pain in her chest and abdomen. She was rushed to intensive care and within days was unconscious and on a breathing tube. The doctors said there was no more she could do. Leroy’s wife was suddenly and unexpectedly dead.

As Leroy tried to cope with the loss of his longtime wife, their son Randy suddenly became sick with the same symptoms. He was born with the same genetic kidney disease as his mother, and was receiving regular dialysis treatments. His wife, a dialysis nurse, tried desperately to revive him but it was no use. Randy died just three weeks after his mother.

Both Bonnie and Randy were victims of tainted heparin, batches of the drug manufactured in China and later found to have been contaminated with over-sulfated chondroitin sulfate (OSCS). The Hubleys were just two of more than 80 deaths caused by the contaminated heparin. Several hundreds more were sickened by the drug before the FDA recalled batches made in the Baxter International Chinese plant. To date, the FDA has recalled 13 different contaminated medical products containing heparin from various companies.

Last week had U.S. Marshals raided Celsus Laboratories Inc., and found 11 lots of the tainted blood thinner that had not been removed. The recalls and FDA crackdowns come too late for the Hubley family and for the hundreds of families affected by the contaminated heparin. We need to be assured that the contaminated heparin is removed for good so that no more lives are in jeopardy.

SOURCE: Heparin Recall › Time shares story of family affected by heparin contamination

“It’s really horrible for two reasons: one, that a company that knows that their product is not a good product that should be distributed and they’ve been told so,” said Dr. Lynne Wagoner, a Christ Hospital Heart Specialist, who was quoted in the story by WTOL-TV in Toledo, Ohio.

Earlier this month, U.S. Marshals seized a total of 11 lots of the blood thinner at Celsus Laboratories Inc. Heparin was recalled earlier this year after an FDA investigation found that batches of the blood thinner were contaminated with over-sulfated chondroitin sulfate (OACA) at a manufacturing plant in China. The investigation was launched after more than 80 Americans died and hundreds more fell ill after receiving the medication.

The FDA said Celsus Laboratories did not sufficiently carry out the recall process by notifying customers of the contaminant in the heparin it provided. The company distributes both heparin lithium and heparin sodium USP, both of which fell under the recall. As a result, the FDA issued an advisory to manufacturers who may have purchased heparin from Celsus Laboratories to contact the company to make certain they are not using a product from the contaminated batch.

The FDA has recalled 13 different contaminated medical products containing heparin from various companies.

SOURCE: Heparin Recall › Doctors outraged by heparin seizure

The FDA ordered U.S. Marshals to seize the products today. Mike Chappell, acting associate commissioner for regulatory affairs for the FDA is quoted as saying, “This action will help prevent this contaminated heparin from finding its way into the marketplace.”

Earlier this year, heparin manufactured by Baxter International, Inc., was found to be contaminated with OSCS. That heparin also contained components manufactured in China, which is believed to be the source of the contamination. The Baxter contamination led to hundreds of injuries and 81 deaths.

The FDA news release states that the agency has initiated 13 recalls of multiple contaminated medical products containing heparin from several companies, to date this year.

Information in the news release indicates the Celsus heparin entered the United States before the establishment of FDA import controls for the drug, and was reviewed by the FDA after it was processed at Celsus as a part of the agency’s process to implement the controls.

The release also indicates that the FDA knew about the contamination in April 2008, when it warned Celsus Laboratories during an inspection that the company’s actions to notify customers about the contaminant were insufficient. The FDA says it warned Celsus again that it needed to step up its efforts to notify customers about the potential hazard in a May 8, 2008 letter. Finally, today the FDA seized the contaminated product from the lab.

Manufacturers who may have purchased heparin from Celsus are urged to contact the company immediately to make sure they are not using any heparin from the since-seized lots. The product does not meet acceptable quality standards, the release says.

SOURCE: Heparin Recall › Contaminated heparin removed from Cinnicinnati plant